Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Aortic Valve Stenosis Clinical Trial

Official title:

Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03851068
• Other study ID #: FOLDAX CP-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Foldax, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Description:

The Foldax Polymer Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 40 patients. These patients will be followed up to 5 years after implantation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is 18 years or older

2. Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement

3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial

4. Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

Exclusion Criteria:

1. Requires multiple valve replacement / repair

2. Requires emergency surgery

3. Has had prior valve surgery

4. Requires a surgical procedure outside of the cardiac area

5. Requires a cardiac procedure other than a CABG or root enlargement

6. Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device

7. Has active endocarditis/myocarditis or within 3 months to the scheduled surgery

8. Has renal insufficiency as determined by creatinine (S-Cr) level as = 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit

9. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery

10. Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery

11. Has life expectancy to less than 12 months

12. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery

13. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism

14. Echocardiographic left ventricular ejection fraction <25%

15. Echocardiographic evidence of an intra-cardiac thrombus or vegetation

16. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery

17. Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy

18. Has prior organ transplant or is currently an organ transplant candidate

19. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial

20. Pregnant, lactating or planning to become pregnant during the duration of participation in trial

21. Currently incarcerated or unable to give voluntary informed consent

22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant

23. Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump

24. Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis

Intervention

Device:
• Foldax Tria Aortic Valve
Aortic Valve Replacement

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
United States	OhioHealth Riverside	Columbus	Ohio
United States	William Beaumont Hospital	Detroit	Michigan
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Ascension Via Christi St. Francis Hospital	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Foldax, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments	The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis	12 months following patient enrollment completion
Primary	Primary Safety Endpoints: Surgical Valve Events Rate Assessment	The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death	12 months following patient enrollment completion
Primary	Primary Effectiveness Endpoint: Hemodynamic Performance Assessment	Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement.	12 months following patient enrollment completion
Primary	Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment	Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.	12 months following patient enrollment completion
Secondary	Secondary Endpoints: Stroke	Assessment of patient experiencing a stroke verified by imaging and or physical exam	5 years following patient enrollment
Secondary	Secondary Endpoint: Transient Ischemic Attack	Assessment of patient having a TIA verified by imaging and or physical exam	5 Years following patient enrollment
Secondary	Secondary Endpoint: ICU Duration of Stay	Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes.	30 days post procedure
Secondary	Secondary Endpoint: Ventilation Time	Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes	30 Days post procedure
Secondary	Secondary Endpoint: New Onset Atrial Fibrillation	New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review	12 Months post procedure
Secondary	Secondary Endpoint: Length of Stay in Hospital	Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes.	30 days post procedure
Secondary	Secondary Endpoint: Readmission	Patient readmission to the hospital post discharge measured by date/time	30 days post discharge
Secondary	Secondary Endpoint: Hemolysis screen	Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments	12 months post procedure
Secondary	Secondary Endpoint: Change in Quality of Life (QOL)	Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire	12 months post procedure